[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07715591":3,"trial-entities:NCT07715591":106,"trial-summary:NCT07715591":109},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":20,"study_type":32,"primary_purpose":33,"phases":34,"enrollment_info":36,"interventions":39,"primary_outcomes":54,"secondary_outcomes":58,"sex":72,"minimum_age":73,"maximum_age":73,"healthy_volunteers":74,"eligibility_criteria":75,"std_ages":79,"locations":83,"central_contacts":101,"overall_officials":103,"references":104,"see_also_links":105},"NCT07715591","IRB-25-2639","Randomized Controlled Trial of the STEIN Protocol: A Neuroplastic Pain Education and Guided Breathing Intervention During Awake Cataract Surgery","RECRUITING","2026-09-01","2026-07","2026-07-23","2026-06-10","University of California, Los Angeles","OTHER",true,"This randomized controlled trial evaluates whether a standardized perioperative neuroplastic intervention: the STEIN Protocol (Strategies and Techniques for Enhancing Integration and Neuroplasticity), consisting of pain neuroscience education, guided imagery, and paced breathing, reduces intraoperative analgesic and anxiolytic requirements.\n\nSecondary outcomes include patient-reported pain, anxiety, satisfaction, and postoperative recovery following cataract surgery.\n\nReduced intraoperative sedative and analgesic requirements may reflect improved patient comfort and autonomic regulation while minimizing medication-related adverse effects.","The STEIN Protocol is a randomized behavioral intervention designed to evaluate whether standardized, non-pharmacologic interventions can help patients have a more comfortable and safe surgical experience.\n\nCataract surgery provides a highly standardized operative model with minimal procedural variability, making it well suited for evaluating perioperative behavioral interventions while minimizing confounding from surgical complexity.\n\nThe intervention is based on contemporary models of pain neuroscience, which propose that cognitive appraisal, expectancy, autonomic regulation, and attentional processes influence pain perception independent of tissue injury.\n\nParticipants in the study will receive standard cataract surgery, with some patients also taking part in the STEIN Protocol. This includes watching a short educational video before surgery, following slow, guided breathing during the procedure, and practicing brief breathing exercises at home for one week after surgery. The intervention is designed to reduce sympathetic arousal and promote parasympathetic regulation through standardized paced breathing and guided cognitive attention.\n\nThe intervention is intended to modify cognitive appraisal, attentional focus, and autonomic regulation, thereby influencing pain perception throughout the perioperative period.\n\nThe study will compare pain levels, medication use, recovery, and patient satisfaction between groups to determine whether this standardized, scalable approach can improve the surgical experience and potentially benefit patients undergoing many types of surgery in the future.\n\nWe hypothesize that participants receiving the STEIN Protocol will require less intraoperative anxiolytic and analgesic medication while reporting lower pain, lower anxiety, and greater satisfaction than participants receiving standard care.\n\nSurgical technique, anesthetic management, questionnaire administration, and postoperative follow-up will be standardized across study groups.\n\nAdherence to each component of the intervention will be documented to assess intervention fidelity.",[18,19],"Cataract","Cataract (Post-operative Cataract Surgery Follow-up)",[21,22,23,24,25,26,27,28,29,30,31],"Cataract Surgery","Pain Neuroscience Education","Guided Imagery","Guided Breathing","Perioperative Care","Anxiety","Patient Satisfaction","Mind-Body Medicine","Meditation","Breathwrok","Pain","INTERVENTIONAL","TREATMENT",[35],"NA",{"count":37,"type":38},300,"ESTIMATED",[40,46,50],{"type":41,"name":42,"description":43,"armGroupLabels":44},"DEVICE","Music and Guided Imagery","Participants wear open-ear headphones during cataract surgery. Every 3 minutes, a voice will ask if the patient would like more relaxing medication or pain medication.\n\nParticipants receive the STEIN Protocol, consisting of preoperative pain neuroscience education, intraoperative audio-guided paced breathing and guided imagery, and postoperative home breathing exercises.\n\nThe open-ear headphones allow participants to hear and communicate with the surgeon and operating room staff at all times. The audio may be stopped at any time if requested or clinically indicated. No additional medications or medical procedures are administered as part of the intervention, and all other aspects of surgical and anesthetic care remain unchanged.",[45],"Music + Guided Imagery",{"type":41,"name":47,"description":48,"armGroupLabels":49},"Control","Participants wear open-ear headphones during cataract surgery. Every 3 minutes, a voice will ask if the patient would like more relaxing medication or pain medication.",[47],{"type":41,"name":51,"description":52,"armGroupLabels":53},"Music Only","Participants wear open-ear headphones during cataract surgery. Every 3 minutes, a voice will ask if the patient would like more relaxing medication or pain medication.\n\nParticipants receive the music protocol, consisting of preoperative pain neuroscience education, intraoperative music, and postoperative home breathing exercises.\n\nThe open-ear headphones allow participants to hear and communicate with the surgeon and operating room staff at all times. The audio may be stopped at any time if requested or clinically indicated. No additional medications or medical procedures are administered as part of the intervention, and all other aspects of surgical and anesthetic care remain unchanged.",[51],[55],{"measure":56,"timeFrame":57},"Total cumulative intraoperative dose of anxiolytic and analgesic medications (midazolam [mg], fentanyl [mcg], and additional rescue medications, recorded separately).","From initiation of surgery until completion of surgery.",[59,63,65,68],{"measure":60,"description":61,"timeFrame":62},"Iowa Satisfaction with Anesthesia Scale (ISAS)","Validated clinical survey instrument","Within 30 minutes of surgery completion",{"measure":64,"description":61,"timeFrame":62},"Numeric Rating Scale pain score (0-10)",{"measure":66,"description":61,"timeFrame":67},"Amsterdam Preoperative Anxiety and Information Scale (APAIS)","30 minutes prior to surgery",{"measure":69,"description":70,"timeFrame":71},"Additional questions","Investigator-developed exploratory questionnaire evaluating perceived comfort, communication, perceived control, and overall surgical experience.","Within 30 minutes after surgery completion","ALL",null,false,{"inclusion":76,"exclusion":77,"raw_text":78},[],[],"Inclusion Criteria:\n\nAdults undergoing elective cataract surgery under topical anesthesia who are able to provide informed consent and complete study procedures.\n\nExclusion Criteria:\n\nInability to provide informed consent Inability to comply with study procedures Complex or combined cataract surgery General anesthesia Medical, neurologic, psychiatric, or respiratory conditions interfering with study participation Requirement for modified anesthetic protocols Inability to complete postoperative breathing exercises or follow-up assessments",[80,81,82],"CHILD","ADULT","OLDER_ADULT",[84],{"facility":85,"status":7,"city":86,"state":87,"zip":88,"country":89,"contacts":90,"geoPoint":98},"Stein Eye Institute - University of California Los Angeles","Los Angeles","California","90025","United States",[91,96],{"name":92,"role":93,"phone":94,"email":95},"Shawn R Lin, MD, MS, MBA","CONTACT","310-206-7955","slin@jsei.ucla.edu",{"name":92,"role":97},"PRINCIPAL_INVESTIGATOR",{"lat":99,"lon":100},34.05223,-118.24368,[102],{"name":92,"role":93,"phone":94,"email":95},[],[],[],{"nct_id":4,"conditions":107,"biomarkers":108},[18],[],{"nct_id":4,"found":14,"summary":110,"prompt_version":120},{"design":111,"status":112,"heading":113,"summary":114,"follow_up":115,"word_count":116,"commitments":117,"compensation":118,"drugs_mentioned":119},"This is a randomized controlled trial planning to enroll 300 participants. Participants will be assigned to one of three groups: STEIN Protocol, Music Only, or a Control group.","completed","Study of STEIN Protocol for Cataract Surgery","This study is testing a new approach called the STEIN Protocol during awake cataract surgery. The STEIN Protocol includes education about pain, guided imagery, and paced breathing. Researchers want to see if this protocol can reduce the amount of relaxing medication (midazolam) and pain medication (fentanyl) you might need during surgery. You would wear open-ear headphones during surgery, and a voice would ask every 3 minutes if you need more medication. The study is for adults having elective cataract surgery. We don't know the current recruitment status.","The primary outcome measures medication use from the start to the completion of surgery. Postoperative recovery is also a secondary outcome.",87,"Participants will receive preoperative pain neuroscience education, intraoperative audio-guided paced breathing or music, and practice brief breathing exercises at home for one week after surgery.","Not stated in the trial record.",[],"v2"]